Flexibility: A Study to Assess the Impact of Darbepoetin Alfa in Subjects withNon-Myeloid Malignancies With Anemia Due to Chemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00144131
Recruitment Status : Completed
First Posted : September 5, 2005
Last Update Posted : May 24, 2013
Information provided by (Responsible Party):

Brief Summary:
This study will compare the efficacy (non-inferiority) of darbepoetin alfa (Aranesp®) extended dose schedule administration (EDS) versus darbepoetin alfa administered once per week (QW) in the treatment of anemia in subjects with non-myeloid malignancies receiving multi-cycle chemotherapy.

Condition or disease Intervention/treatment Phase
Anemia Cancer Drug: Aranesp® Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Flexibility: A Study to Assess the Impact of Once Per Cycle Correction and Maintenance Dosing of Darbepoetin Alfa in Subjects With Non-Myeloid Malignancies With Anemia Due to Chemotherapy
Study Start Date : August 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia
U.S. FDA Resources

Primary Outcome Measures :
  1. Change in hemoglobin (Hb) in chemotherapy induced anemia

Secondary Outcome Measures :
  1. Patient-reported outcomes including overall health, fatigue, and daily activities

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Inclusion Criteria: - Subjects with active non-myeloid malignancy(ies) including lymphocytic leukemias - Receiving chemotherapy and expected to receive at least 8 additional weeks of cyclic cytotoxic chemotherapy anticipated to be on a QW, every other week (Q2W) or every three weeks (Q3W) schedule - Anemia due to cancer and/or chemotherapy (screening Hb less than 11.0 g/dL) - Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 Exclusion Criteria: - Subjects with acute myelogenous leukemia (AML), chronic myelogenous leukemia (CML), or myelodysplastic syndromes (MDS) - Other underlying hematologic disorder, which could cause anemia, other than a non-myeloid malignancy - Active bleeding - Severe, unstable, active chronic inflammatory disease (e.g., ulcerative disease, peptic ulcer disease, rheumatoid arthritis) - Active, unstable systemic or chronic infection - Planned elective surgery during the study where significant blood loss is expected - Known iron deficiency (to be considered iron deficient a subject must have both of the following: a saturated transferrin less than 15% and ferritin less than 10 ng/mL at screening) - Unstable angina, or uncontrolled cardiac arrhythmia - Hypertension (diastolic blood pressure greater than 100 mmHg) - Inadequate renal and/or liver function (e.g., creatinine greater than 2 X upper limit of normal (ULN) and/or transaminase greater than 5 X ULN) - History of pure red blood cell aplasia - Known positive human immunodeficiency virus (HIV) test or acquired immune deficiency syndrome (AIDS) status - Known positive antibody response to any erythropoietic agent - Subject has known sensitivity to any erythropoietic agents, the study drug, or its excipients to be administered during this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00144131

Sponsors and Collaborators
Study Director: MD Amgen

Additional Information:
Publications of Results:
Responsible Party: Amgen Identifier: NCT00144131     History of Changes
Other Study ID Numbers: 20040262
First Posted: September 5, 2005    Key Record Dates
Last Update Posted: May 24, 2013
Last Verified: May 2013

Keywords provided by Amgen:
Chemotherapy, Anemia
Aranesp®, rHuEPO
Chemotherapy Induced Anemia
non-myeloid malignancy
Non-Myeloid Malignancies

Additional relevant MeSH terms:
Hematologic Diseases
Darbepoetin alfa